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OtherResearch Paper

Preservative efficacy testing of refrigerated pharmaceuticals: choice of challenging isolate and storage temperature

Seyed Sadeq Mousavi Ghahfarrokhi, Zeinab Zarei, Khadijeh Hamidian, Sepideh Nikrou, Mohammad-Reza Seidi, Hossein Jamalifar and Nasrin Samadi
PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2024-003021; DOI: https://doi.org/10.5731/pdajpst.2024-003021.1
Seyed Sadeq Mousavi Ghahfarrokhi
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
2Pharmaceutical Quality Assurance Research Center, The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran, Iran
3Universal Scientific Education and Research Network (USERN), Tehran, Iran
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Zeinab Zarei
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
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Khadijeh Hamidian
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
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Sepideh Nikrou
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
2Pharmaceutical Quality Assurance Research Center, The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran, Iran
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Mohammad-Reza Seidi
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
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Hossein Jamalifar
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
2Pharmaceutical Quality Assurance Research Center, The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran, Iran
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Nasrin Samadi
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
2Pharmaceutical Quality Assurance Research Center, The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran, Iran
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  • For correspondence: samadin@tums.ac.ir
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Abstract

The antimicrobial effectiveness testing assesses the performance of preservatives and/or antimicrobial substances added to multi-use sterile or non-sterile dosage forms, protecting these products from microbiological growth. In this study, insulin products underwent the European Pharmacopoeia and the United States Pharmacopeia antimicrobial preservative effectiveness tests at both room and refrigerated temperatures. Notably, a psychrotolerant strain, Serratia marcescens, originally isolated from a refrigerated pharmaceutical product, was included in the antimicrobial effectiveness testing. When evaluated against the compendial requirements, both NPH and REG insulin stored at room temperature successfully met the European Pharmacopoeia-A criteria and the United States Pharmacopeia standards. However, although both formulations stored under refrigeration conformed to the United States Pharmacopeia criteria, they failed to satisfy the European Pharmacopoeia-A criteria at contact times of less than 7 days. The reductions in Serratia marcescens counts were the same at both incubation temperatures. This study indicated that for sterile multi-dose vials, performing the antimicrobial effectiveness testing at both room and refrigerated temperatures might give more accurate indication of antimicrobial preservative efficacy.

  • Preservative
  • Antimicrobial effectiveness test
  • NPH insulin
  • REG insulin
  • psychrotolerant strain
  • Received October 10, 2024.
  • Accepted March 24, 2025.
  • Copyright © 2025, Parenteral Drug Association

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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
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Preservative efficacy testing of refrigerated pharmaceuticals: choice of challenging isolate and storage temperature
Seyed Sadeq Mousavi Ghahfarrokhi, Zeinab Zarei, Khadijeh Hamidian, Sepideh Nikrou, Mohammad-Reza Seidi, Hossein Jamalifar, Nasrin Samadi
PDA Journal of Pharmaceutical Science and Technology Apr 2025, pdajpst.2024-003021; DOI: 10.5731/pdajpst.2024-003021.1

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Preservative efficacy testing of refrigerated pharmaceuticals: choice of challenging isolate and storage temperature
Seyed Sadeq Mousavi Ghahfarrokhi, Zeinab Zarei, Khadijeh Hamidian, Sepideh Nikrou, Mohammad-Reza Seidi, Hossein Jamalifar, Nasrin Samadi
PDA Journal of Pharmaceutical Science and Technology Apr 2025, pdajpst.2024-003021; DOI: 10.5731/pdajpst.2024-003021.1
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Keywords

  • Preservative
  • Antimicrobial effectiveness test
  • NPH insulin
  • REG insulin
  • psychrotolerant strain

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